Determining trustworthiness and safety of remote consulting during the COVID-19 pandemic in primary healthcare for chronic disease populations in Nigeria and Tanzania
| ISRCTN | ISRCTN17941313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17941313 |
| Secondary identifying numbers | Grant Ref: EP/V028936/1 |
- Submission date
- 09/12/2020
- Registration date
- 20/01/2021
- Last edited
- 20/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
During the COVID-19 pandemic, face-to-face healthcare appointments put health workers and their patients at risk. Patients are reluctant to attend clinics for management of chronic diseases, for example, to collect medicines, which may harm their health. Remote healthcare, by phone or Internet, is advised by the World Health Organisation. This is difficult in Nigeria and Tanzania due to limited digital infrastructure, so the study team have developed a training programme for health workers called REaCH. REaCH enables health workers to deliver trusted and safe care using the phone and limited internet availability.
This study will look in particular at patients with type 2 diabetes, hypertension, Chronic Obstructive Pulmonary Disease (COPD), and/or coronary heart disease who typically require contact with health facilities several times per year. These conditions are common and patients are vulnerable to poor outcomes from communicable diseases.
REaCH training aims to increase the number of appointments held by phone for patients with long-term conditions. The study team want to test whether these remote appointments are as acceptable, safe, and trustworthy as face-to-face appointments. It is hoped that the programme will strengthen health care across Africa following REaCH training, that health workers and patients will be protected from COVID-19, and that stronger scientific research teams will be developed in Nigeria.
Who can participate?
Adult patients receiving healthcare for type 2 diabetes, hypertension, COPD, and/or coronary heart disease from participating care facilities.
What does the study involve?
This study will involve 20 health clinics in both Nigeria and Tanzania and train healthcare workers in remote consulting in two of the clinics a month for ten months. The study team will collect monthly information on appointment types and the number of prescriptions and investigations given by each clinic. Ten to 15 patients in each clinic per month will be asked to complete questionnaires about their trust in their healthcare provider, and the knowledge, beliefs, and skills that enable them to manage their long-term condition.
What are the possible benefits and risks of participating?
There are no direct benefits for the patients taking part, except knowing they are potentially helping future patients.
There are no expected risks associated with participation in this study. If any of the participants become upset or distressed during the interview sessions they will be offered time out of the interview and then they may carry on or stop the interview completely. In addition, the services of a counsellor will be made available at no cost to the participants should their services be needed.
Where is the study run from?
Ibadan Clinical Trials Unit, University of Ibadan (Nigeria)
When is the study starting and how long is it expected to run for?
From August 2020 to March 2022
Who is funding the study?
The UK Research and Innovation (UKRI) Collective Fund comprising the UKRI (UK), the Global Challenges Research Fund (GCRF) (UK), and the Newton Fund. (UK)
Who is the main contact?
Ms Rebecca Rogers
rebecca.e.rogers@kcl.ac.uk
Contact information
Scientific
King's College London
Faculty of Nursing, Midwifery and Palliative Care
James Clark Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
 ORCID ID |
0000-0003-1281-1401 |
|---|---|
| Phone | +44 (0)20 7848 3108 |
| jackie.sturt@kcl.ac.uk |
Public
King's College London
Faculty of Nursing, Midwifery and Palliative Care
James Clark Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
| ORCID ID |
0000-0002-5313-5705 |
|---|---|
| Phone | +44 (0)20 7848 3620 |
| rebecca.e.rogers@kcl.ac.uk |
Study information
| Study design | Multi-centre international stepped-wedge cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN17941313_PIS_v1_30Oct20.pdf |
| Scientific title | COVID-19: Determining trustworthiness and safety of REmote Consulting in primary Healthcare for chronic disease populations in Nigeria and Tanzania using a stepped wedge design - The REaCH Trial |
| Study acronym | REaCH |
| Study objectives | REaCH training will increase the rate of remote consulting. This remote consulting will not affect patient trust in, and the safety of, primary care consultations for long-term conditions. |
| Ethics approval(s) | Approved 11/11/2020, King's College London Research Ethics Board (King's College London, Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Road, London SE1 9NH; +44 (0)20 7848 4020/4070/4077; rec@kcl.ac.uk) ref: HR-20/21-21006 |
| Health condition(s) or problem(s) studied | Chronic disease, type 2 diabetes, hypertension, chronic obstructive pulmonary disease, coronary heart disease |
| Intervention | Current intervention as of 12/06/2023: The intervention involves REaCH training for healthcare workers to deliver remote consulting via mobile phone to patients and will be compared to care as usual. The study will take place in Nigeria (urban/MIC/West Africa) and Tanzania (rural/LIC/East Africa). In each country, 20 primary care facility clusters (each cluster is made up of one or more clinic/facility, which between them has ≥10 healthcare workers) will be recruited. Tier 1 trainees are healthcare workers with a higher diploma or degree who speak, read and write in English; Tier 2 trainees are other cadres e.g. community health workers, pharmacy assistants, and medical assistants who may communicate in English or in local languages. The tier 1 and tier 2 trainees work as a team within the facility. Health workers will be in the trial for between one and six months depending upon when they receive REaCH training and whether they take part in the process evaluation. At the beginning of the intervention, all clusters are randomised into groups of two (a sequence) and allocated a monthly timeslot to receive REaCH training over a ten-month period. This will be done by generating a random number for each cluster and then clusters assigned to each sequence in ascending order of the generated number. The randomisation will be conducted by the trial statistician who will be blinded to cluster name. The intervention implementers and clinics will not be blinded to allocation sequence as this is impractical given the need to plan and prepare training. In each local trial delivery team, one investigator and 1 research assistant will remain blinded to the month during which REaCH training was delivered to each cluster. Each facility is given a unique identification number consisting of 4 digits. 4 digit numbers are used to make it more difficult for the research team to recall cluster IDs when discussing with the unblinded education team. This will reduce bias when monthly data collection is undertaken. When education and research teams meet together, clusters will be referred to by identification number only. At the beginning of every data collection activity the researcher will remind the health worker or patient participant not to reveal whether the facility has undertaken REaCH training. Data entry will be undertaken by a database assistant who will be blinded to whether the data is from a cluster in the intervention or the control. At the bi-weekly trial team meetings, there will be an agenda item to check with every blinded member whether they think they have been unblinded in relation to the identity of a randomised cluster during the previous two weeks. All UK investigators will be blind to cluster randomisation except the Birmingham trial statistician. Data from the Open Cohort dataset are taken at the first of the month from all Clusters both before and after they have received their individual randomised monthly training. The training goes on for 10 months, from month 1 to month 11, but data will be gathered from month 0 through month 12 following the stepped wedge design. Thirty participants are randomly sampled from each Cluster every month with the expectation that twenty of these will give informed consent to take part in the structured interviews (approximately 60 min duration) and undertake the questionnaires (10-15 participants in each cluster, 20-30 participants in each sequence, and therefore 200-300 participants each month in each country). Patient participants will remain in the trial for the time it takes to complete two questionnaires (which are estimates to take less than 60 minutes). If they offer consent to be interviewed they will remain in the study for a further six weeks from the point of conducting the survey to give sufficient time for the sampling framework to be consulted and an interview to be set up and completed. The Physician Humanistic Behaviour Questionnaire (PHBQ) will be used to determine patient trust in healthcare providers as it assesses the degree to which healthcare providers communicate humanistically with their patients. Humanistic communications engender trust between the patient and the healthcare worker. The PHBQ has face and content validity with patients and health workers for assessing these behaviours during remote consultations. The Patient Activation Measure (PAM-13) will be used to determine patient engagement with their health as this questionnaire aims to understand the knowledge, beliefs and skills required by people to enable them to manage their long-term conditions. It has been successfully used in African populations. Previous research found that patient activation increases with remote consulting and that the PAM-13 has face and content validity for assessing the impact of remote consulting. The data from each trial will be analysed using a generalised linear mixed model framework standard for stepped-wedge cluster designs. Data from each time point will be considered a repeated cross-section given the difficulty linking observations between patients in different time periods. The primary outcomes are of two types: count data (the number of consultations by mode of delivery and the number of prescriptions) and a continuous score (the patient trust outcome). Previous intervention: The intervention involves REaCH training for healthcare workers to deliver remote consulting via mobile phone to patients and will be compared to care as usual. The study will take place in Nigeria (urban/MIC/West Africa) and Tanzania (rural/LIC/East Africa). In each country, 20 primary care facility clusters (each cluster is made up of one or more clinic/facility, which between them has ≥10 healthcare workers) will be recruited. Tier 1 trainees are healthcare workers with a higher diploma or degree who speak, read and write in English; Tier 2 trainees are other cadres e.g. community health workers, pharmacy assistants, and medical assistants who may communicate in English or in local languages. The tier 1 and tier 2 trainees work as a team within the facility. Health workers will be in the trial for between one and six months depending upon when they receive REaCH training and whether they take part in the process evaluation. At the beginning of the intervention, all clusters are randomised into groups of two (a sequence) and allocated a monthly timeslot to receive REaCH training over a ten-month period. This will be done by generating a random number for each cluster and then clusters assigned to each sequence in ascending order of the generated number. The randomisation will be conducted by the trial statistician who will be blinded to cluster name. The intervention implementers and clinics will not be blinded to allocation sequence as this is impractical given the need to plan and prepare training. In each local trial delivery team, one investigator and 1 research assistant will remain blinded to the month during which REaCH training was delivered to each cluster. Each facility is given a unique identification number consisting of 4 digits. 4 digit numbers are used to make it more difficult for the research team to recall cluster IDs when discussing with the unblinded education team. This will reduce bias when monthly data collection is undertaken. When education and research teams meet together, clusters will be referred to by identification number only. At the beginning of every data collection activity the researcher will remind the health worker or patient participant not to reveal whether the facility has undertaken REaCH training. Data entry will be undertaken by a database assistant who will be blinded to whether the data is from a cluster in the intervention or the control. At the bi-weekly trial team meetings, there will be an agenda item to check with every blinded member whether they think they have been unblinded in relation to the identity of a randomised cluster during the previous two weeks. All UK investigators will be blind to cluster randomisation except the Birmingham trial statistician. Data from the Open Cohort dataset are taken at the first of the month from all Clusters both before and after they have received their individual randomised monthly training. The training goes on for 10 months, from month 1 to month 11, but data will be gathered from month 0 through month 12 following the stepped wedge design. Thirty participants are randomly sampled from each Cluster every month with the expectation that twenty of these will give informed consent to take part in the structured interviews (approximately 60 min duration) and undertake the questionnaires (20 participants in each cluster, 40 participants in each sequence, and therefore 400 participants each month in each country). Patient participants will remain in the trial for the time it takes to complete two questionnaires (which are estimates to take less than 60 minutes). If they offer consent to be interviewed they will remain in the study for a further six weeks from the point of conducting the survey to give sufficient time for the sampling framework to be consulted and an interview to be set up and completed. The Physician Humanistic Behaviour Questionnaire (PHBQ) will be used to determine patient trust in healthcare providers as it assesses the degree to which healthcare providers communicate humanistically with their patients. Humanistic communications engender trust between the patient and the healthcare worker. The PHBQ has face and content validity with patients and health workers for assessing these behaviours during remote consultations. The Patient Activation Measure (PAM-13) will be used to determine patient engagement with their health as this questionnaire aims to understand the knowledge, beliefs and skills required by people to enable them to manage their long-term conditions. It has been successfully used in African populations. Previous research found that patient activation increases with remote consulting and that the PAM-13 has face and content validity for assessing the impact of remote consulting. The data from each trial will be analysed using a generalised linear mixed model framework standard for stepped-wedge cluster designs. Data from each time point will be considered a repeated cross-section given the difficulty linking observations between patients in different time periods. The primary outcomes are of two types: count data (the number of consultations by mode of delivery and the number of prescriptions) and a continuous score (the patient trust outcome). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Patient trust in healthcare provider measured using the Physician Humanistic Behaviour Questionnaire (PHBQ) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months 2. Face to face consultation rate defined as the number of visits per month for the eligible patient population where the patient is seen in person by the consulting health worker measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months 3. Remote consultation rate defined as the number of visits per month for the eligible patient population conducted using a telephone measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months 4. Prescribing rate defined as the number of prescriptions issued and collected to the eligible patient population per month. This outcome is a proxy for patient safety as a change in this outcome is an indicator of changes in safety and confidence measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months |
| Secondary outcome measures | 1. Patient engagement with their health measured using the Patient Activation Measure (PAM-13) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months 2. Patient safety assessed from the number of investigations processed by the facility monthly, matched to the patient’s consultation type (where an increase may indicate a higher safety threshold when the person cannot be examined, and a decrease may indicate missed health needs) measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months |
| Overall study start date | 21/08/2020 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Open Cohort = 12,022; Surveyed Sample participants = 4134 |
| Total final enrolment | 12022 |
| Key inclusion criteria | 1. Receiving healthcare from participating primary care facilities 2. Able to speak, read and write in English or local language 3. Give consent to participate in the study 4. Aged ≥18 years 5. Receiving treatment and/or monitoring for ≥1 of the following conditions: 5.1. Type 2 diabetes 5.2. Hypertension 5.3. Chronic obstructive pulmonary disease 5.4. Coronary heart disease 6. Contact with health facility ≥3 times per year |
| Key exclusion criteria | 1. No access to a mobile phone or fixed phone in the community 2. Identified by health workers as nearing the end of life or currently severely ill 3. Carers consulting on another person’s behalf 4. Unable to provide informed consent |
| Date of first enrolment | 18/03/2021 |
| Date of final enrolment | 13/03/2022 |
Locations
Countries of recruitment
- Nigeria
- Tanzania
Study participating centres
Queen Elizabeth II Road
Oritamefa
Ibadan
-
Nigeria
Box 53
Ifakara
-
Tanzania
Sponsor information
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | www.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- GCRF
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- The Newton Fund, NF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in open access peer review journals, presentation at conferences and engagement with policy makers in partner countries and the UK including governments, NGOs, and digital health and telecommunications companies. We will undertake stakeholder activities within each country building on our existing stakeholder communities and engaging with the local facilities to interpret and extend the impact of our findings. |
| IPD sharing plan | Current IPD sharing statement as of 12/06/2023: The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Jackie Sturt, King’s College London, Jackie.sturt@kcl.ac.uk, and Professor Akinyinka Omigbodun, University of Ibadan omigbodun@yahoo.com. Trial data are available with immediate effect. Informed consent was obtained from the denominator participants who undertook the surveys and interviews but not from the numerator population as none of their personal data was transferred out of the clinic and so that population represented a minimal risk to the research participants. If we had requested informed consent this would have required the disclosure of contact information to research staff and represented an unnecessary transfer of identifiable data. This is detailed in our protocol v.2 20.08/21 and was approved by our Ethics Committees. For comments on data anonymization, please see protocol v.2. 20.08.21, Informed consent, pg 4-5; Data management/Data transfer pages 12-13. Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Rebecca Rogers, rebecca.e.rogers@kcl.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 30/10/2020 | 20/01/2021 | No | Yes |
| Protocol file | version 2 | 20/08/2021 | 12/08/2022 | No | No |
| Abstract results | Abstracts from the IDF World Diabetes Congress 2022 - 0837 | 15/03/2023 | 07/06/2023 | No | No |
| Statistical Analysis Plan | 12/06/2023 | No | No | ||
| Results article | 01/11/2023 | 20/10/2023 | Yes | No |
Additional files
- ISRCTN17941313_PIS_v1_30Oct20.pdf
- Uploaded 20/01/2021
- 39155 Protocol v2 20Aug2021.pdf
- ISRCTN17941313_SAP.pdf
Editorial Notes
20/10/2023: Publication reference added.
12/06/2023: The following changes have been made and the plain English summary updated accordingly:
1. The Individual participant data (IPD) sharing statement was updated.
2. The statistical analysis plan was uploaded.
3. The target number of participants was changed from "Patients: 20 clusters in Nigeria and 20 clusters in Tanzania; 20 patients in each cluster; a total of 400 patients in each country with a grand total of 800 patients from both countries." to "Open Cohort = 12,022; Surveyed Sample participants = 4134".
4. The intervention has been changed.
07/06/2023: The following changes were made to the trial record and the plain English summary updated accordingly:
1. The overall study end date has been changed from 20/02/2022 to 31/03/2022.
2. The total final enrolment was added.
3. The recruitment start date has been changed from 01/02/2020 to 18/03/2021.
4. The recruitment end date has been changed from 01/12/2021 to 13/03/2022.
5. The intention to publish date has been changed from 01/11/2022 to 01/09/2023.
6. The individual participant data (IPD) sharing statement and summary were added.
12/08/2022: The following changes were made to the trial record:
1. The trial website was added.
2. Uploaded protocol (not peer-reviewed) as an additional file.
15/12/2020: Trial’s existence confirmed by King's College London Research Ethics Board.
